BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET DREAM SOCK

    MDR report key: 23499684 · Received November 7, 2025

    Report

    Report Number
    MW5178670
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 5, 2025
    Manufacturer
    OWLET BABY CARE
    Product Code
    QYU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OWLET DREAM SOCK BURNED INFANTS FOOT. SOCK AND SENSOR CLEANED 2 DAYS BEFORE ACCORDING TO INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228658 OWLET DREAM SOCK INFANT PULSE RATE AND OXYGEN SATURATION MONITOR FOR OVER-THE-COUNTER USE QYU OWLET BABY CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other